Biomedical research key to pandemic preparedness, US health leaders say

Comprehensive biomedical research must continue its crucial role in preparing the world for the next pandemic or other far-reaching public health emergency, whether it be caused by a novel influenza strain, Ebola, or some other transmissible pathogen, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID) and colleagues wrote in a commentary in the Journal of the American Medical Association (JAMA) yesterday.

"The basic research portfolio leads naturally into and is complemented by investments in countermeasure development," the experts write. "Although treatments and vaccines are essential countermeasures, so too are rapid, deployable, and point-of-care diagnostics. The latter are key to an effective response in an evolving pandemic."

The commentary examines three basic approaches to pandemic preparedness: (1) pathogen-specific work, (2) platform-based technologies, and (3) prototype-pathogen efforts, highlighting each using vaccine development as an example. The authors conclude that all three approaches combine to produce the best pandemic preparedness.

Pathogen-specific research prioritizes diseases known to be dangerous, such as Ebola virus. In platform-based approaches, researchers focus on developing customizable techniques that can incorporate genetic material from the pandemic pathogen into the platform to protect recipients against a specific disease. The prototype-pathogen approach can shorten the time needed to create vaccines by employing platform-based methods.

The experts conclude, "Infectious disease outbreaks have been with humankind forever and will continue to occur. Whether dealing with HIV/AIDS, SARS, Ebola, Zika, or the inevitable unanticipated pathogen that will surely emerge, research has played and will play a critical role before, during, and after the outbreak." Oct 4 JAMAcommentary Oct 5 NIAID press release

HHS invests $2 million in research on reusable respirators

The US Department of Health and Human Services (HHS) announced this week that it is investing $1.97 million in the research and development of respirators that can be used up to 100 times to better protect healthcare providers during pandemics.

The HHS's Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) has awarded Applied Research Associates, Inc., of Albuquerque, N.M., a 15-month contract for the company to design and test a next-generation respirator prototype that will be a hybrid of the N95 filtering facepiece respirator and a half-mask elastomeric respirator, HHS said in a news release.

If successfully developed and approved by the US Food and Drug Administration, the mask could be autoclaved at hospitals to sanitize it for reuse. The reusable respirator could also be incorporated into routine healthcare settings, which would make it readily available in a pandemic or other public health emergency, HHS said.

Reusable masks could cut stockpiling and distribution costs to taxpayers and ensure wider availability for first responders and healthcare workers, the agency added. The novel respirators could provide protection from multiple threats, including anthrax, Ebola, and pandemic influenza.

"During public health emergencies, particularly in severe pandemics, equipment may be in short supply to protect the professionals who are essential to saving lives," said BARDA Director Rick Bright, PhD. "By sponsoring the development of a novel, reusable respirator, we aim to make such personal protective equipment widely available during an emergency at the lowest possible cost." Oct 2 HHS news release

HHS, Regeneron partner on monoclonal therapies for flu, other diseases

HHS's ASPR recently announced that it had formed a public-private partnership with Regeneron Pharmaceuticals to develop a monoclonal antibody platform to produce a new treatment for severe flu and emerging infectious diseases.

In an Oct 3 statement, HHS said BARDA will share oversight and cost of developing the new therapies with Regeneron, with an initial contribution worth $18.7 million. Regeneron, based on Tarrytown, N.Y., has already developed candidate monoclonal antibody therapies for Ebola and Middle East respiratory syndrome coronavirus (MERS-CoV). The technology platform has the potential to shorten the treatment development timeline to months instead of years.

A few days ago, HHS announced $40.4 million in Project BioShield funding for Regeneron's monoclonal antibody cocktail for Ebola, putting the treatment on track for inclusion in the Strategic National Stockpile.

According to HHS, the ASPR and Regeneron will collaborate with an "other transaction agreement" (OTA), using authority granted by the Pandemic and All Hazards Preparedness Act of 2006. OTAs enable funding and advanced research of medical products needed in a public health emergency.Oct 3 HHS press release Oct 2 CIDRAP News story "Project BioShield adds Ebola vaccines, drugs to US stockpile"